id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id FDA-2004-N-0318-0006,FDA,FDA-2004-N-0318,"Transcript of November 18, 2004 Stakeholder Meeting",Other,Transcript(s),2004-12-29T05:00:00Z,2004,12,,,2025-09-26T17:48:39Z,,0,0,090000648047300c FDA-2004-N-0318-0003,FDA,FDA-2004-N-0318,"Transcript of November 18, 2004 Stakeholder Meeting",Other,Transcript(s),2004-12-29T05:00:00Z,2004,12,,,2025-09-26T17:47:25Z,,0,0,0900006480473009 FDA-2004-N-0318-0004,FDA,FDA-2004-N-0318,"Transcript of November 18, 2004 Stakeholder Meeting",Other,Transcript(s),2004-12-29T05:00:00Z,2004,12,,,2025-09-26T17:47:41Z,,0,0,090000648047300a FDA-2004-P-0401-0001,FDA,FDA-2004-P-0401,"Acknowledgment Letter from FDA/CDER to Andrx Pharmaceuticals, Inc.",Other,Acknowledgement Letter/Receipt,2004-12-29T05:00:00Z,2004,12,2004-12-27T05:00:00Z,,2025-03-28T01:00:45Z,,0,0,09000064804744d0 FDA-2004-P-0401-0002,FDA,FDA-2004-P-0401,"Acknowledgment Letter from FDA/CDER to Andrx Pharmaceuticals, Inc.",Other,Acknowledgement Letter/Receipt,2004-12-29T05:00:00Z,2004,12,2004-12-27T05:00:00Z,,2025-03-27T21:26:48Z,,0,0,09000064804744d6 FDA-2004-N-0318-0002,FDA,FDA-2004-N-0318,"Transcript of November 18, 2004 Stakeholder Meeting",Other,Transcript(s),2004-12-29T05:00:00Z,2004,12,,,2025-09-26T17:47:08Z,,0,0,0900006480473008 FDA-2004-N-0318-0005,FDA,FDA-2004-N-0318,"Transcript of November 18, 2004 Stakeholder Meeting",Other,Transcript(s),2004-12-29T05:00:00Z,2004,12,,,2025-09-26T17:48:17Z,,0,0,090000648047300b FDA-2004-N-0318-0011,FDA,FDA-2004-N-0318,MDUFMA and the GMP Inspection Program,Other,Testimony,2004-12-29T00:00:00Z,2004,12,,,2025-04-30T16:56:03Z,,0,0,0900006480473015 FDA-2004-N-0318-0012,FDA,FDA-2004-N-0318,BIMO and MDUFMA,Other,Testimony,2004-12-29T00:00:00Z,2004,12,,,2025-04-30T16:59:49Z,,0,0,0900006480473016 FDA-2004-N-0318-0015,FDA,FDA-2004-N-0318,Inspection by Accredited persons (AP) Program,Other,Testimony,2004-12-29T00:00:00Z,2004,12,,,2025-04-30T17:15:34Z,,0,0,0900006480473019 FDA-2004-N-0318-0014,FDA,FDA-2004-N-0318,CBER and MDUFMA Quantitative Goals,Other,Testimony,2004-12-29T00:00:00Z,2004,12,,,2025-04-30T17:11:01Z,,0,0,0900006480473018 FDA-2004-N-0318-0009,FDA,FDA-2004-N-0318,Premarket Review Performance Goals,Other,Testimony,2004-12-29T00:00:00Z,2004,12,,,2025-04-30T18:51:39Z,,0,0,0900006480473011 FDA-2004-N-0318-0013,FDA,FDA-2004-N-0318,Modular PMA Updates,Other,Testimony,2004-12-29T00:00:00Z,2004,12,,,2025-04-30T17:07:48Z,,0,0,0900006480473017 FDA-2004-N-0318-0007,FDA,FDA-2004-N-0318,"Agenda for November 18, 2004 Meeting",Other,List (LST),2004-12-29T00:00:00Z,2004,12,,,2025-04-30T16:39:05Z,,0,0,090000648047300d FDA-2004-N-0318-0010,FDA,FDA-2004-N-0318,CBER MDUFMA Activity,Other,Testimony,2004-12-29T00:00:00Z,2004,12,,,2025-04-30T18:52:55Z,,0,0,0900006480473012 FDA-2004-N-0318-0016,FDA,FDA-2004-N-0318,Reuse of Single Use Devices,Other,Testimony,2004-12-29T00:00:00Z,2004,12,,,2025-04-30T17:18:33Z,,0,0,090000648047301b FDA-2004-N-0318-0008,FDA,FDA-2004-N-0318,Financial Aspects of MDUFMA,Other,Testimony,2004-12-29T00:00:00Z,2004,12,,,2025-04-30T18:50:19Z,,0,0,090000648047300e FDA-2004-D-0118-0005,FDA,FDA-2004-D-0118,Guidance,Supporting & Related Material,GDL-Guidance,2004-12-28T05:00:00Z,2004,12,,,2008-04-12T00:34:19Z,,0,0,090000648046fb07 FDA-2004-N-0308-0008,FDA,FDA-2004-N-0308,Supporting Statement - List of Attachments,Supporting & Related Material,Background Material,2004-12-28T05:00:00Z,2004,12,,,2025-04-11T12:21:49Z,,0,0,0900006480472ecb FDA-2004-N-0308-0007,FDA,FDA-2004-N-0308,Supporting Statement - Attachment C - Outline of Questionnaires with Indication of Whether Questions are the Same as the Previous Data Collection,Supporting & Related Material,Background Material,2004-12-28T05:00:00Z,2004,12,,,2025-04-11T12:19:30Z,,0,0,0900006480472eca FDA-2004-D-0118-0007,FDA,FDA-2004-D-0118,FDA,Notice,NAD-Notice of Availability of Data,2004-12-28T05:00:00Z,2004,12,2004-12-27T05:00:00Z,2005-12-29T04:59:59Z,2008-04-12T00:34:19Z,,0,0,090000648046fb09 FDA-2004-D-0373-0004,FDA,FDA-2004-D-0373,Background Material,Supporting & Related Material,GDL-Guidance,2004-12-28T05:00:00Z,2004,12,,,2008-04-12T00:36:00Z,,0,0,0900006480473724 FDA-2004-N-0308-0010,FDA,FDA-2004-N-0308,Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infant Feeding Practices Study II,Notice,Notice of Approval,2004-12-28T05:00:00Z,2004,12,,,2025-04-09T20:03:59Z,04-28136,0,0,0900006480472ecd FDA-2004-D-0118-0006,FDA,FDA-2004-D-0118,Guidance,Supporting & Related Material,GDL-Guidance,2004-12-28T05:00:00Z,2004,12,,,2008-04-12T00:34:19Z,,0,0,090000648046fb08 FDA-2004-D-0373-0002,FDA,FDA-2004-D-0373,Background Material,Supporting & Related Material,GDL-Guidance,2004-12-28T05:00:00Z,2004,12,,,2008-04-12T00:36:00Z,,0,0,0900006480473722 FDA-2004-N-0308-0004,FDA,FDA-2004-N-0308,Supporting Statement for OMB Review - Infant Feeding Practices Study II,Supporting & Related Material,Background Material,2004-12-28T05:00:00Z,2004,12,,,2025-04-11T12:14:14Z,,0,0,0900006480472ec7 FDA-2003-D-0031-0010,FDA,FDA-2003-D-0031,FDA,Notice,NAL-Notice of Approval,2004-12-28T05:00:00Z,2004,12,2004-12-23T05:00:00Z,,2008-04-12T00:54:06Z,,0,0,09000064804815bc FDA-2004-D-0373-0001,FDA,FDA-2004-D-0373,FDA,Notice,NAD-Notice of Availability of Data,2004-12-28T05:00:00Z,2004,12,2004-12-28T05:00:00Z,2005-12-29T04:59:59Z,2008-04-12T00:36:00Z,,0,0,0900006480473721 FDA-2004-D-0373-0003,FDA,FDA-2004-D-0373,Background Material,Supporting & Related Material,GDL-Guidance,2004-12-28T05:00:00Z,2004,12,,,2008-04-12T00:36:00Z,,0,0,0900006480473723 FDA-1998-N-0043-0003,FDA,FDA-1998-N-0043,Gastroenterology-Urology Devices; Classification for External Penile Rigidity Devices,Rule,Final Rule,2004-12-28T05:00:00Z,2004,12,,,2024-09-17T12:34:00Z,04–28252,0,0,090000648056e637 FDA-2003-D-0031-0009,FDA,FDA-2003-D-0031,Supporting Statement,Supporting & Related Material,SS-Supporting Statement,2004-12-28T05:00:00Z,2004,12,,,2008-04-12T00:54:07Z,,0,0,09000064804815ba FDA-2004-N-0308-0006,FDA,FDA-2004-N-0308,Supporting Statement - List of Attachments,Supporting & Related Material,Background Material,2004-12-28T05:00:00Z,2004,12,,,2025-04-11T12:17:06Z,,0,0,0900006480472ec9 FDA-2004-N-0054-0003,FDA,FDA-2004-N-0054,Medwatch - The FDA Safety Information and Adverse Event Reporting Program (Sample),Supporting & Related Material,Background Material,2004-12-28T05:00:00Z,2004,12,,,2025-09-24T15:16:08Z,,0,0,090000648046e8f8 FDA-2004-N-0054-0002,FDA,FDA-2004-N-0054,Medwatch - The FDA Safety Information and Adverse Event Reporting Program (Sample),Supporting & Related Material,Background Material,2004-12-28T05:00:00Z,2004,12,,,2025-09-24T15:15:44Z,,0,0,090000648046e8f7 FDA-2003-D-0031-0008,FDA,FDA-2003-D-0031,Supporting Statement,Supporting & Related Material,SS-Supporting Statement,2004-12-28T05:00:00Z,2004,12,,,2008-04-12T00:54:07Z,,0,0,09000064804815b9 FDA-2004-N-0569-0017,FDA,FDA-2004-N-0569,FDA,Notice,NEC-Notice of Extension,2004-12-28T05:00:00Z,2004,12,2004-12-27T05:00:00Z,2005-02-02T04:59:59Z,2008-04-12T00:46:19Z,,0,0,0900006480483331 FDA-2004-N-0308-0005,FDA,FDA-2004-N-0308,Supporting Statement for OMB Review - Infant Feeding Practices Study II,Supporting & Related Material,Background Material,2004-12-28T05:00:00Z,2004,12,,,2025-04-11T12:13:22Z,,0,0,0900006480472ec8 FDA-2004-N-0254-0001,FDA,FDA-2004-N-0254,Agency Information Collection Activities; Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements,Notice,60 Day Proposed Information Collection,2004-12-28T00:00:00Z,2004,12,2004-12-27T05:00:00Z,2005-02-26T04:59:59Z,2025-05-13T19:08:00Z,04-28137,0,0,0900006480471b8b FDA-2004-N-0054-0001,FDA,FDA-2004-N-0054,Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: Food and Drug Administration Medical Products Reporting Program,Notice,60 Day Proposed Information Collection,2004-12-28T00:00:00Z,2004,12,2004-12-27T05:00:00Z,2005-02-26T04:59:59Z,2025-05-13T09:00:41Z,04-28138,0,0,090000648046e8f4 FDA-2004-N-0497-0001,FDA,FDA-2004-N-0497,Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Laser System,Notice,Notice of Final Rule,2004-12-28T00:00:00Z,2004,12,,,2025-05-12T19:12:18Z,04-28251,0,0,09000064804766b6 FDA-2004-N-0308-0009,FDA,FDA-2004-N-0308,Supporting Statement - Attachment C - Outline of Questionnaires with Indication of Whether Questions are the Same as the Previous Data Collection,Supporting & Related Material,Background Material,2004-12-28T00:00:00Z,2004,12,,,2025-05-21T23:04:08Z,,0,0,0900006480472ecc FDA-1980-N-0049-0088,FDA,FDA-1980-N-0049,Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review,Other,Report,2004-12-27T05:00:00Z,2004,12,,,2020-05-21T12:41:00Z,,0,0,09000064805b99f4 FDA-1980-N-0049-0091,FDA,FDA-1980-N-0049,Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review,Other,Report,2004-12-27T05:00:00Z,2004,12,,,2020-05-21T12:51:32Z,,0,0,09000064805b99f7 FDA-1980-N-0049-0089,FDA,FDA-1980-N-0049,Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review,Other,Report,2004-12-27T05:00:00Z,2004,12,,,2020-05-21T12:44:51Z,,0,0,09000064805b99f5 FDA-2004-P-0345-0002,FDA,FDA-2004-P-0345,"Acknowledgment Letter from FDA DMB to Lachman Consultant Services, Inc.",Other,ACK-Acknowledgement Letter,2004-12-27T05:00:00Z,2004,12,2004-12-27T05:00:00Z,,2025-03-27T20:51:13Z,,0,0,09000064804734a7 FDA-2004-P-0096-0002,FDA,FDA-2004-P-0096,"Acknowledgment Letter from FDA/DMB to Lachman Consultant Services, Inc.",Other,Acknowledgement Letter/Receipt,2004-12-27T05:00:00Z,2004,12,2004-12-27T05:00:00Z,,2025-03-27T19:34:05Z,,0,0,090000648046f4ed FDA-2004-P-0363-0001,FDA,FDA-2004-P-0363,"Acknowledgment Letter from FDA/DMB to Methapharm, Inc.",Other,Acknowledgement Letter/Receipt,2004-12-27T05:00:00Z,2004,12,2004-12-27T05:00:00Z,,2025-03-27T21:01:11Z,,0,0,090000648047364f FDA-1980-N-0049-0087,FDA,FDA-1980-N-0049,Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review,Other,Report,2004-12-27T05:00:00Z,2004,12,,,2020-05-21T12:27:53Z,,0,0,09000064805b99f3 FDA-1980-N-0049-0092,FDA,FDA-1980-N-0049,Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review,Other,Report,2004-12-27T05:00:00Z,2004,12,,,2020-05-21T12:56:57Z,,0,0,09000064805b99f8 FDA-1980-N-0049-0090,FDA,FDA-1980-N-0049,Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review,Other,Report,2004-12-27T05:00:00Z,2004,12,,,2020-05-21T12:47:47Z,,0,0,09000064805b99f6 FDA-2004-D-0182-0003,FDA,FDA-2004-D-0182,Guidance,Supporting & Related Material,GDL-Guidance,2004-12-27T05:00:00Z,2004,12,,,2008-04-12T00:34:48Z,,0,0,0900006480470216 FDA-2004-D-0182-0001,FDA,FDA-2004-D-0182,FDA,Notice,NAD-Notice of Availability of Data,2004-12-27T05:00:00Z,2004,12,2004-12-20T05:00:00Z,2005-03-22T04:59:59Z,2008-04-12T00:34:48Z,,0,0,0900006480470214 FDA-2004-D-0182-0002,FDA,FDA-2004-D-0182,Guidance,Supporting & Related Material,GDL-Guidance,2004-12-27T05:00:00Z,2004,12,,,2008-04-12T00:34:48Z,,0,0,0900006480470215 FDA-2004-P-0345-0001,FDA,FDA-2004-P-0345,"Acknowledgment Letter from FDA/DMB to Lachman Consultant Services, Inc.",Other,Acknowledgement Letter/Receipt,2004-12-27T05:00:00Z,2004,12,2004-12-27T05:00:00Z,,2025-03-27T20:38:11Z,,0,0,09000064804734a2 FDA-2004-P-0096-0001,FDA,FDA-2004-P-0096,"Acknowledgment Letter from FDA/DMB to Lachman Consultant Services, Inc.",Other,Acknowledgement Letter/Receipt,2004-12-27T05:00:00Z,2004,12,2004-12-27T05:00:00Z,,2025-03-27T19:29:18Z,,0,0,090000648046f4e6 FDA-2004-D-0122-0003,FDA,FDA-2004-D-0122,See FDA-2004-D-0122-0002,Supporting & Related Material,GDL-Guidance,2004-12-23T05:00:00Z,2004,12,,,2009-05-11T15:47:27Z,,0,0,090000648046fbc1 FDA-2004-M-0072-0001,FDA,FDA-2004-M-0072,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applicatio11,Notice,Notice of Data Availability,2004-12-23T05:00:00Z,2004,12,2004-12-14T05:00:00Z,,2025-08-01T22:43:29Z,04-27387,0,0,090000648046ed12 FDA-2004-D-0122-0002,FDA,FDA-2004-D-0122,Compliance Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Draft Guidance,Other,GDL-Guidance (Supporting and Related Materials),2004-12-23T05:00:00Z,2004,12,,,2013-08-11T04:06:32Z,,0,0,090000648046fbbe FDA-2002-N-0153-0104,FDA,FDA-2002-N-0153,Notice; public meeting on final rule.,Notice,NM-Notice of Meeting,2004-12-23T05:00:00Z,2004,12,2004-12-06T05:00:00Z,,2009-08-18T14:10:53Z,,0,0,09000064804933ed FDA-2002-N-0153-0105,FDA,FDA-2002-N-0153,Final Rule - Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (pp 1-100),Notice,NFR-Notice of Final Rule,2004-12-23T05:00:00Z,2004,12,2004-12-06T05:00:00Z,,2009-08-18T14:21:36Z,,0,0,09000064804933f0 FDA-2002-N-0153-0106,FDA,FDA-2002-N-0153,Final Rule - Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (pp 201-300),Notice,NFR-Notice of Final Rule,2004-12-23T05:00:00Z,2004,12,2004-12-06T05:00:00Z,,2009-08-18T14:25:30Z,,0,0,09000064804933f3 FDA-2004-G-0002-0002,FDA,FDA-2004-G-0002,"Draft Guidance for Industry and FDA Staff; Draft Guidance for Records, Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002",Supporting & Related Material,Guidance,2004-12-23T05:00:00Z,2004,12,,,2025-11-13T21:09:57Z,,0,0,090000648046a718 FDA-2004-M-0325-0001,FDA,FDA-2004-M-0325,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications,Notice,Notice of Data Availability,2004-12-23T05:00:00Z,2004,12,2004-12-14T05:00:00Z,,2025-08-01T21:25:35Z,04-27387,0,0,09000064804730d8 FDA-2004-M-0071-0001,FDA,FDA-2004-M-0071,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications,Notice,Notice of Data Availability,2004-12-23T05:00:00Z,2004,12,2004-12-14T05:00:00Z,,2025-07-29T23:29:00Z,04-27387,0,0,090000648046ecfe FDA-2004-M-0138-0001,FDA,FDA-2004-M-0138,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Application,Notice,Notice of Data Availability,2004-12-23T05:00:00Z,2004,12,2004-12-14T05:00:00Z,,2025-07-30T00:17:04Z,04-27387,0,0,090000648046fde8 FDA-2004-M-0516-0001,FDA,FDA-2004-M-0516,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Application,Notice,Notice of Data Availability,2004-12-23T05:00:00Z,2004,12,2004-12-14T05:00:00Z,,2025-08-05T23:47:06Z,04-27387,0,0,0900006480477cb7 FDA-2004-M-0512-0001,FDA,FDA-2004-M-0512,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applicatio,Notice,Notice of Data Availability,2004-12-23T05:00:00Z,2004,12,2004-12-14T05:00:00Z,,2025-07-29T22:10:36Z,04-27387,0,0,0900006480477c56 FDA-2004-M-0196-0001,FDA,FDA-2004-M-0196,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications,Notice,Notice of Data Availability,2004-12-23T05:00:00Z,2004,12,2004-12-14T05:00:00Z,,2025-07-29T22:58:57Z,04-27387,0,0,0900006480470b87 FDA-2004-M-0075-0001,FDA,FDA-2004-M-0075,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications,Notice,Notice of Data Availability,2004-12-23T05:00:00Z,2004,12,2004-12-14T05:00:00Z,,2025-08-01T17:53:40Z,04-27387,0,0,090000648046ed44 FDA-2004-M-0563-0001,FDA,FDA-2004-M-0563,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications,Notice,Notice of Data Availability,2004-12-23T05:00:00Z,2004,12,2004-12-14T05:00:00Z,,2025-08-01T22:08:53Z,04-27387,0,0,09000064804815c2 FDA-2004-G-0002-0001,FDA,FDA-2004-G-0002,"Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Availability",Notice,Notice of Data Availability,2004-12-23T05:00:00Z,2004,12,2004-12-09T05:00:00Z,2005-01-25T04:59:59Z,2025-11-14T10:00:23Z,04-26931,0,0,090000648046a701 FDA-2003-F-0457-0001,FDA,FDA-2003-F-0457,FDA,Notice,NFR-Notice of Final Rule,2004-12-23T05:00:00Z,2004,12,2004-12-22T05:00:00Z,,2008-04-12T00:57:04Z,,0,0,09000064804a26a0 FDA-2004-D-0122-0001,FDA,FDA-2004-D-0122,Draft Compliance Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Availability,Notice,NAD-Notice of Availability of Data,2004-12-23T05:00:00Z,2004,12,2004-12-08T05:00:00Z,2005-02-08T04:59:59Z,2009-05-11T15:38:00Z,,0,0,090000648046fbbc FDA-2004-D-0122-0004,FDA,FDA-2004-D-0122,See FDA-2004-D-0122-0002,Supporting & Related Material,GDL-Guidance,2004-12-23T05:00:00Z,2004,12,,,2009-05-11T15:46:51Z,,0,0,090000648046fbc2 FDA-2002-N-0153-0108,FDA,FDA-2002-N-0153,Final Rule - Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (pp 101-200),Notice,NFR-Notice of Final Rule,2004-12-23T05:00:00Z,2004,12,2004-12-06T05:00:00Z,,2009-08-18T14:28:56Z,,0,0,09000064804933f9 FDA-2004-M-0393-0001,FDA,FDA-2004-M-0393,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications,Notice,Notice of Data Availability,2004-12-23T05:00:00Z,2004,12,2004-12-14T05:00:00Z,,2025-08-01T18:58:41Z,04-27387,0,0,0900006480474397 FDA-2004-M-0515-0001,FDA,FDA-2004-M-0515,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applicatio11,Notice,Notice of Data Availability,2004-12-23T05:00:00Z,2004,12,2004-12-14T05:00:00Z,,2025-08-04T20:22:21Z,04-27387,0,0,0900006480477c92 FDA-2004-M-0078-0001,FDA,FDA-2004-M-0078,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications,Notice,Notice of Data Availability,2004-12-23T05:00:00Z,2004,12,2004-12-14T05:00:00Z,,2025-08-05T00:10:21Z,04-27387,0,0,090000648046ed79 FDA-2002-N-0153-0107,FDA,FDA-2002-N-0153,Final Rule - Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (pp 301-344),Notice,NFR-Notice of Final Rule,2004-12-23T05:00:00Z,2004,12,2004-12-06T05:00:00Z,,2009-08-18T14:32:34Z,,0,0,09000064804933f6 FDA-2003-M-0456-0001,FDA,FDA-2003-M-0456,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications,Notice,Notice of Approval,2004-12-23T05:00:00Z,2004,12,2004-12-14T05:00:00Z,,2025-04-14T14:01:44Z,,0,0,09000064804a2682 FDA-2004-P-0084-0001,FDA,FDA-2004-P-0084,Notice of Temporary Permit,Notice,N-Notice,2004-12-23T05:00:00Z,2004,12,2004-12-08T05:00:00Z,2004-12-10T04:59:59Z,2025-03-21T21:54:45Z,69FR71418,0,0,090000648046ee04 FDA-2004-M-0077-0001,FDA,FDA-2004-M-0077,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications,Notice,Notice of Data Availability,2004-12-23T05:00:00Z,2004,12,2004-12-14T05:00:00Z,,2025-08-04T22:26:11Z,04-27387,0,0,090000648046ed6a FDA-2004-M-0197-0001,FDA,FDA-2004-M-0197,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications,Notice,Notice of Data Availability,2004-12-23T05:00:00Z,2004,12,2004-12-14T05:00:00Z,,2025-08-04T21:55:14Z,04-27387,0,0,0900006480470b95 FDA-2004-M-0198-0001,FDA,FDA-2004-M-0198,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications,Notice,Notice of Data Availability,2004-12-23T05:00:00Z,2004,12,2004-12-14T05:00:00Z,,2025-08-05T21:14:54Z,04-27387,0,0,0900006480470ba2 FDA-2004-M-0140-0001,FDA,FDA-2004-M-0140,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Application,Notice,Notice of Data Availability,2004-12-23T05:00:00Z,2004,12,2004-12-14T05:00:00Z,,2025-08-05T22:33:49Z,04-27387,0,0,090000648046fe0c FDA-2004-P-0338-0001,FDA,FDA-2004-P-0338,HFA-305 to Valeant Pharmaceuticals International,Other,ACK-Acknowledgement Letter,2004-12-22T05:00:00Z,2004,12,,,2008-04-12T00:49:25Z,,0,0,09000064804732f6 FDA-2004-P-0338-0002,FDA,FDA-2004-P-0338,HFA-305 to Valeant Pharmaceuticals International,Other,ACK-Acknowledgement Letter,2004-12-22T05:00:00Z,2004,12,,,2008-04-12T00:49:25Z,,0,0,09000064804732ff FDA-2004-S-0442-0003,FDA,FDA-2004-S-0442,"Agenda for November 8, 2004 meeting",Other,LST-List,2004-12-21T05:00:00Z,2004,12,,,2008-04-12T00:52:54Z,,0,0,0900006480474a96 FDA-2004-V-0030-0002,FDA,FDA-2004-V-0030,HFA-305 to Varian Medical Systems,Other,ACK-Acknowledgement Letter,2004-12-21T05:00:00Z,2004,12,,,2008-04-12T00:52:58Z,,0,0,090000648046a954 FDA-2004-D-0247-0002,FDA,FDA-2004-D-0247,GUIDANCE,Supporting & Related Material,GDL-Guidance,2004-12-21T05:00:00Z,2004,12,,,2008-04-12T00:35:26Z,,0,0,0900006480471afc FDA-2004-S-0442-0006,FDA,FDA-2004-S-0442,"Attendees to November 8, 2004 meeting",Other,LST-List,2004-12-21T05:00:00Z,2004,12,,,2008-04-12T00:52:54Z,,0,0,0900006480474a99 FDA-2004-N-0311-0001,FDA,FDA-2004-N-0311,Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Health Claims on Food Packages,Notice,60 Day Proposed Information Collection,2004-12-21T05:00:00Z,2004,12,2004-12-10T05:00:00Z,2005-02-09T04:59:59Z,2025-06-04T23:03:14Z,04-27119,0,0,0900006480472f08 FDA-1993-F-0015-0004,FDA,FDA-1993-F-0015,"Reference 1 Findlay, Forrest and Smith Neutron-induced activation of food re: Irradiation in the Production, Processing and Handling of Food; Final Rule",Supporting & Related Material,Background Material,2004-12-21T05:00:00Z,2004,12,,,2016-02-16T18:08:05Z,,0,0,09000064804fa571 FDA-1993-F-0015-0005,FDA,FDA-1993-F-0015,"Reference 3 Easterly et al Assessment of Petition to Use Pulsed Fast Neutron Analysis (PFNA) in Inspection of Shipping Containers Containing Foods re: Irradiation in the Production, Processing and Handling of Food; Final Rule",Supporting & Related Material,Background Material,2004-12-21T05:00:00Z,2004,12,,,2016-02-16T18:17:12Z,,0,0,09000064804fa572 FDA-2004-V-0362-0002,FDA,FDA-2004-V-0362,HFA-305 to G and G Sound and Lighting,Other,ACK-Acknowledgement Letter,2004-12-21T05:00:00Z,2004,12,,,2008-04-12T00:53:37Z,,0,0,0900006480473647 FDA-2004-N-0435-0001,FDA,FDA-2004-N-0435,Medical Devices; General Hospital and Personal Use Devices; Classification of Implantable Radiofrequency Transponder System for Patient Identification and Health Information,Notice,Notice of Final Rule,2004-12-21T05:00:00Z,2004,12,,,2025-09-26T23:21:09Z,04-27077,0,0,090000648047496c FDA-1993-F-0015-0001,FDA,FDA-1993-F-0015,"Irradiation in the Production, Processing, and Handling of Food; Final rule",Notice,Notice of Final Rule,2004-12-21T05:00:00Z,2004,12,2004-12-21T05:00:00Z,2005-01-22T04:59:59Z,2016-02-16T22:00:55Z,,0,0,09000064804fa56b FDA-2004-S-0442-0004,FDA,FDA-2004-S-0442,"Agenda for November 8, 2004 meeting",Other,LST-List,2004-12-21T05:00:00Z,2004,12,,,2008-04-12T00:52:55Z,,0,0,0900006480474a97 FDA-2004-D-0247-0003,FDA,FDA-2004-D-0247,GUIDANCE,Supporting & Related Material,GDL-Guidance,2004-12-21T05:00:00Z,2004,12,,,2008-04-12T00:35:26Z,,0,0,0900006480471afd FDA-2004-V-0030-0001,FDA,FDA-2004-V-0030,HFA-305 to Varian Medical Systems,Other,ACK-Acknowledgement Letter,2004-12-21T05:00:00Z,2004,12,,,2008-04-12T00:52:58Z,,0,0,090000648046a950